The analysis of regulations will include evaluation for overlap, inconsistency, unnecessary complexity, and inadequacy. The report summarizing this work will be definitive. The analysis of the impact of regulations on cancer will address several specific areas of impact. These are: availability and rate of development of new drugs; development of research protocols and their fate in review; informed consent process; and status of the cancer patient in clinical research. Determine both the degree to which present regulations accord cancer a unique status and the capacity to accommodate the unique aspects of this disease. Explore attitudes toward and experience with clinical research in cancer therapy from the vantage points of: the patient; the research oncologist; the clinical review committee; and the regulatory agencies.